MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LAMP, SURGICAL

Model Number ARD568604941

Device Problems Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - lucea 50.It was stated the label was torn and the paint was peeling from the spring arm.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of the surgical lights - lucea 50.It was stated the label was torn and the paint was peeling from the spring arm.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.According to the information provided by the service technician, the device has been repaired by the replacement of defective parts.It was established that when the event occurred, the surgical light did not meet its specification as particles of paint and torn label were missing, and it contributed to the event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issues have never led to serious injury or worse, to our knowledge.The subject matter expert at the manufacturing site has evaluated investigated issues and concluded: all maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.¿ disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow detecting the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.About the torn label the most probable root cause is excessive friction during cleaning or inappropriate cleaning products.We believe that overall the devices on the market are performing correctly.Given the circumstances, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - lucea 50.Initially, there was no indication of a reportable issue.Based on the information provided by the getinge employee, during the visit in the facility on (b)(6) 2022 it was revealed the label was torn and the paint was peeling from the spring arm.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

The correction of b5 describe event and problem and h10 complaint summary deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on (b)(6) 2022 getinge became aware of an issue with one of surgical lights - lucea 50.It was stated the label was torn and the paint was peeling from the spring arm.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on (b)(6) 2022 getinge became aware of an issue with one of surgical lights - lucea 50.Initially, there was no indication of a reportable issue.Based on the information provided by the getinge employee, during the visit in the facility on (b)(6) 2022 it was revealed the label was torn and the paint was peeling from the spring arm.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Previous h10 complaint summary: getinge became aware of an issue with one of the surgical lights - lucea 50.It was stated the label was torn and the paint was peeling from the spring arm.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.According to the information provided by the service technician, the device has been repaired by the replacement of defective parts.It was established that when the event occurred, the surgical light did not meet its specification as particles of paint and torn label were missing, and it contributed to the event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issues have never led to serious injury or worse, to our knowledge.The subject matter expert at the manufacturing site has evaluated investigated issues and concluded: all maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.¿ disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow detecting the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.About the torn label the most probable root cause is excessive friction during cleaning or inappropriate cleaning products.We believe that overall the devices on the market are performing correctly.Given the circumstances, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.Corrected h10 complaint summary: getinge became aware of an issue with one of surgical lights - lucea 50.Initially, there was no indication of a reportable issue.Based on the information provided by the getinge employee, during the visit in the facility on (b)(6) 2022 it was revealed the label was torn and the paint was peeling from the spring arm.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as particles of paint and torn label were missing, and it contributed to the event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issues have never led to serious injury or worse, to our knowledge.Comparing the install base for lucea 50/100 surgical lights the failure ratios for paint peeling and torn label are very low.The subject matter expert at the manufacturing site has evaluated investigated issues and concluded: all maquet sas products comply with: ¿ iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.¿ iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.¿ paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.¿ disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow detecting the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor pain chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.About the torn label the most probable root cause is excessive friction during cleaning or inappropriate cleaning products.We believe that overall the devices on the market are performing correctly.Given the circumstances, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: LUCEA 50
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 14673656
• MDR Text Key: 301248965
• Report Number: 9710055-2022-00206
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568604941
• Device Catalogue Number: ARD568604941
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1